TyTek Group
DESIGN ENGINEER
Job Description
Job Title: Design Engineer
Department: Technical & Engineering
Reports To: Engineering Manager
Overall Responsibilities:
Generate engineering documentation and specifications in compliance with FDA Medical Device Regulations (including the current Good Manufacturing Practice (cGMP)), ISO 9001 and/or 13485, and European regulatory requirements (Medical Device Regulation - MDR). Responsible for the creation of all materials required for the supply factories to manufacture the product according to both customer’s print and satisfaction.
Essential Duties & Responsibilities include the following:
- Evaluate and Recommend sources for production to include product, required tooling and/or secondary operation services and continually liaise with them to assure good, consistent quality production.
- Evaluate, recommend, and approve outside testing procedures for product as needed in collaboration with the Engineering Manager.
- Experience in design of mechanical assemblies.
- Experience with Solidworks cad software to generate solid models and drawings.
- Knowledge of the capability of manufacturing processes such as stamping, machining, casting, molding, extrusion spinning, coating, ect. Knowledge of soft goods manufacturing/sewing desirable. Knowledge of and experience with electrical assemblies and components is also desirable.
- Knowledge to be able to select for design purposes from metals, plastics, and fabrics.
- Experience in generating Bill of Materials for projects, generating product / packaging specifications.
- Experience in managing projects / project planning and the use of project planning tools is essential.
- Understanding of dimensioning and application of tolerances, including the use of GD&T is also essential.
- Experience in dealing with customers and suppliers during the development of product designs and the release of tooling and manufacturing.
- Knowledge of tooling concepts and the use of draft, parting lines and ejection requirements for molding, casting, and stamping.
- Compliance with standards and regulations established by the Company or relevant regulatory bodies.
- Assist in the evaluation and determination of corrective and preventative actions for any non-conformances, per our ISO 9001 and 13485 Quality Systems.
- Assist in analyzing and evaluating information concerning manufacturing problems corrective actions and preventive actions, quality system concerns, etc. for review by appropriate management personnel.
- Assist manufacturing and planning in inspection and testing activities to ensure continuous control over materials, facilities, and products.
- Other duties may be assigned, as necessary.
Qualifications
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education & Experience
- Minimum of a bachelor’s degree in an engineering discipline with minimum 10 years company experience. Minimum 8 years working in a company with quality systems within an ISO environment.
Language Skills
- Ability to generate, read, and to interpret technical drawings, either hard copy or electronic in commonly used electronic engineering formats and interface with customer’s similar programs.
- Ability to create a technical drawing electronically and all necessary data that can be used for the production facility to manufacture the product.
- Fluency in the use of Solidworks
Mathematical Skills
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Training Required
- All departmental procedures. FDA current Good Manufacturing Practice (cGMP), Unique Device Identification (UDI), ISO 9001, ISO 13485, and Medical Device Regulation (MDR).